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Device Problem
Degraded (1153)
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Patient Problem
Respiratory Failure (2484)
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Event Date 03/21/2024 |
Event Type
Injury
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Manufacturer Narrative
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There is no device information was provided.So, the exact recall number is unknown.Possible recall numbers include z-1972-2021, z-1973-2021, and z-1974-2021.H3 other text : device not returned to the manufacturer.
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Event Description
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The manufacturer was contacted in reference to the voluntary field safety notice / recall notification related to the sound abatement foam in certain cpap, bipap, and mechanical ventilator devices.The manufacturer received information alleging of respiratory failure.The manufacturer was made aware of this complaint through a representative of the customer.Medical intervention was not specified.The manufacture's investigation is ongoing.A follow up report will be submitted when the manufacture's investigation is complete.
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Search Alerts/Recalls
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